A Dose-ranging Study of Orvepitant in Patients With Chronic Refractory Cough

• ClinicalTrials.gov Identifier: NCT02993822
• Recruitment Status: Completed
• First Posted: December 15, 2016
• Last Update Posted: March 13, 2019
• Sponsor: Nerre Therapeutics Ltd.
• Information provided by (Responsible Party): Nerre Therapeutics Ltd.

Study Description

Brief Summary:

The purpose of this study is to determine the effectiveness of three doses of orvepitant, taken once a day, in the treatment of chronic refractory cough.

Condition or disease	Intervention/treatment	Phase
Chronic Refractory Cough	Drug: Orvepitant Maleate; Drug: Placebo	Phase 2

Detailed Description:

A multi-center, double-blind, randomized, parallel group, placebo-controlled dose range study in subjects with chronic refractory cough (CRC).

Doses of orvepitant (10 mg/day, 20 mg/day and 30 mg/day) and placebo will be investigated in four parallel groups.

Each group will compromise of approximately 61 subjects, randomized 1:1:1:1 (approximately 244 subjects in total).

All subjects will enter a three-week screening period to determine eligibility. Eligible subjects will be randomized at the Baseline/Day 1 visit and enter a 12-week double-blind dosing period. During this period there will be four visits at Weeks 2, 4, 8 and 12. There will be a final safety follow-up visit at Week 14.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 315 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Randomized, Placebo Controlled Study of the Efficacy and Safety of Three Doses of Orvepitant in Subjects With Chronic Refractory Cough
• Actual Study Start Date: May 10, 2017
• Actual Primary Completion Date: February 11, 2019
• Actual Study Completion Date: February 25, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Orvepitant 10mg; Orvepitant 10mg tablet, once daily for 12 weeks	Drug: Orvepitant Maleate; Tablet, once daily, oral
Experimental: Orvepitant 20mg; Orvepitant 20mg tablet, once daily for 12 weeks	Drug: Orvepitant Maleate; Tablet, once daily, oral
Experimental: Orvepitant 30mg; Orvepitant 30mg tablet, once daily for 12 weeks	Drug: Orvepitant Maleate; Tablet, once daily, oral
Placebo Comparator: Placebo; Placebo to match tablet, once daily for 12 weeks	Drug: Placebo; Tablet, once daily, oral

Outcome Measures

Primary Outcome Measures :

1. Awake objective cough frequency [ Time Frame: Week 12 ]
   Objective cough frequency measured by ambulatory cough monitoring device

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Key Inclusion Criteria:

• Male and female subjects ≥18 years of age.
• Diagnosis of CRC or unexplained cough for at least 1 year (see ACCP/BTS guidelines attached).
• A awake average cough frequency of ≥10 coughs/ hour, as assessed using an ACM during the screening period.

Key Exclusion Criteria:

• Subjects with respiratory tract infection (<4 weeks prior to study start)
• Current smokers or ex-smokers with <6 months' abstinence or cumulative history of >10 pack years
• Treatment with Angiotensin Converting Enzyme (ACE) inhibitors within 3 months of screening
• FEV1 <80% predicted, measured at screening using spirometry
• History of cystic fibrosis, idiopathic pulmonary fibrosis, clinically significant bronchiectasis, moderate to severe asthma, chronic obstructive pulmonary disease (COPD)
• Any clinically significant abnormal laboratory test result(s)
• Inability to comply with the use of prohibited and allowed medications as described in the protocol.

Contacts and Locations

  Show 42 Study Locations

Sponsors and Collaborators

Nerre Therapeutics Ltd.

More Information

• Responsible Party: Nerre Therapeutics Ltd.
• ClinicalTrials.gov Identifier: NCT02993822 History of Changes
• Other Study ID Numbers: VOLCANO-2
• First Posted: December 15, 2016
• Last Update Posted: March 13, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Maleic acid; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action